Post Marketing Surveillance Study of Biphasic Insulin Aspart 30

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Interventions: Drug: biphasic insulin aspart 30

• Registration Number: NCT01536613
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This study is conducted in Asia. The aim of this study is to review the safety and efficacy of biphasic insulin aspart 30 in post-marketing use.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Primary Completion: 2007-02
• Study Completion: 2007-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-16
• Study First Posted: 2012-02-22
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5346

Inclusion Criteria

• Subjects with diabetes who did not have indications that are contraindicated in the product insert

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BIAsp 30 users	biphasic insulin aspart 30	-

Primary Outcome Measures

Name	Time	Method
Change in body weight

Secondary Outcome Measures

Name	Time	Method
Change in HbA1c (glycosylated haemoglobin)
Occurrence of adverse events (non-serious and serious)
Change in fasting plasma glucose (FPG)